Opioid painkiller debate set for Feb. 7

SPOTLIGHT ON BIOTECH

Anna Edney

Updated 8:40 pm, Tuesday, December 18, 2012

Regulators will reopen debate over opioid painkillers next year as the government considers ways to reconcile the needs of patients suffering chronic ailments with the risks of addiction and recreational drug use.

The Food and Drug Administration plans a two-day public hearing starting Feb. 7 after receiving "comments, petitions and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain." The meeting is intended to help understand how doctors define pain and measures used to limit opioid use, the agency said Tuesday.

The balancing act was highlighted two weeks ago when San Diego-based drugmaker Zogenix Inc. failed to persuade FDA advisers to support approval of the first single-ingredient hydrocodone pill. While the company showed that the medicine worked and presented patients from a trial who said the pill met a need other painkillers hadn't, advisers at the Dec. 7 meeting were swayed by other stories of addiction and death.

"It is as complex an issue as I've seen in my 16 years at FDA," Douglas Throckmorton, deputy director at the agency's office that oversees drug reviews, said at a Dec. 10 conference in Washington. "They are the most commonly prescribed prescription drugs and they're killing people."

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'Not addicts'

About 70 patient advocacy and health care industry and provider groups are seeking to overcome the negative perceptions of painkillers by drawing attention to legitimate patients and their need for access to prescription opioids, which share many of the same narcotic traits as heroin.

There's a difference between being addicted and needing pain medication to complete daily tasks, just as someone with high blood pressure depends on their pills, said Paul Gileno, president of the Middletown, Conn.-based U.S. Pain Foundation. He said there's a stigma pain patients deal with even though "we know we're not addicts."

"If it's safe for us to use, we want it to be available for us so that it can help our pain," said Gileno, who broke his back at his catering business in 2003. "Overdose is horrible and we don't want to see that. We also want access."

Hydrocodone combinations, like acetaminophen-mixed Vicodin, are the most popular pharmacy drugs in the United States, with more than 130 million prescriptions dispensed last year, according to IMS Health, a Parsippany, N.J., data company. The pills were also responsible for 115,739 overdose-related emergency room visits in 2010, double the tally in 2004, according to the Substance Abuse and Mental Health Services Administration.

January meeting

Advisers to the FDA will meet Jan. 24-25 to discuss the risks and benefits of hydrocodone preparations used as pain relievers or cough suppressants. The Drug Enforcement Administration asked the FDA, which regulates pharmaceutical sales, to recommend stricter regulations on those painkillers, which have fewer regulations than pure hydrocodone.

The DEA is seeking to change drug classifications in a way that would require more interaction with doctors for people to obtain those combination products.

Members of the pain forum wrote Congress last month asking lawmakers to convene a task force out of the Department of Health and Human Services or a think tank to come up with ideas to coordinate the government's efforts to stem opioid abuse.